Last updated: January 5, 2023
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting
Phase
2
Condition
Pain
Pain (Pediatric)
Treatment
N/AClinical Study ID
NCT04431778
PHRC-IR 2019 DELAGE
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female (under effective contraception: pill, implant, IUD, sterilization) aged 18 years or older, suffering from peripheral neuropathic pain (DN4 ≥ 4) for more than 3 months, of intensity ≥ 4 on a numerical scale from 0 to 10, and whose analgesictreatment has been stable for more than a month,
- Patients affiliated to the French Social Security system,
- Patients whose free and informed consent has been obtained.
Exclusion
Exclusion Criteria:
- Pregnancy (βHCG+ blood) or breastfeeding,
- Neuropathic pain due to spinal cord or brain injury, phantom limb pain oralgohallucinosis,
- Fibromyalgia or algodystrophy,
- Chronic pain syndrome that the patient cannot distinguish and/or is more intense thanperipheral neuropathic pain,
- Significant abnormalities in liver (transaminases > 3N, cholestasis) and renal (MDRD < 60 mL/min) tests,
- Ongoing comorbidities: cancer, neurodegenerative pathology
- Severe depressive disorder in progress (as determined by the clinician), history ofsuicide attempts or hospitalization for depression,
- Diabetic patients (contraindicated due to the high sugar concentration ofethosuximide, 3g / 5 ml),
- Patients who have previously received ethosuximide (epilepsy or clinical trial),
- Surgery planned throughout the entire trial,
- Medical and surgical history incompatible with the study,
- Dependence on alcohol and/or drugs (for compliance purposes),
- Known allergy to succinimides (ethosuximide, methsuximide, phensuximide),
- Psychotic disorders,
- Epileptic patients,
- Patients benefiting from a legal protection measure (curatorship, guardianship,deprived of liberty or subject to judicial safeguard).
Study Design
Total Participants: 64
Study Start date:
November 01, 2020
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
University Hospital Lyon sud - Pierre Bénite
Lyon, Aura 69310
FranceSite Not Available
Uniervity hospital, Amiens
Amiens, 80000
FranceSite Not Available
Hospital of Annecy Genevois
Annecy,
FranceSite Not Available
CIC, Hospital University, Clermont Ferrand
Clermont-Ferrand,
FranceSite Not Available
University hospital, clermont ferrand
Clermont-Ferrand, 63000
FranceActive - Recruiting
University Hospital, Grenoble
Grenoble,
FranceSite Not Available
CHu Limoges
Limoges,
FranceSite Not Available
Hospital University, Lyon
Lyon,
FranceSite Not Available
University Hospital, Saint Etienne
Saint-Étienne,
FranceSite Not Available
Hospital of Valence
Valence,
FranceSite Not Available
Hospital of Vienne
Vienne,
FranceSite Not Available
Hospital of Voiron
Voiron,
FranceSite Not Available
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